Recruiting

Growth Hormone Therapy

Sponsor:

University of Calgary

Code:

NCT07795736

Conditions

Growth Hormone Deficiency

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Not applicable (observational study)

Study Details

Brief summary:

The goal of this observational study is to characterize the impact of growth hormone deficiency (GHD) on quality of life, symptom burden, and sleep in adults with traumatic brain injury (TBI), and to evaluate whether these outcomes improve with growth hormone replacement therapy.

The main questions it aims to answer are:

  • Does quality of life, as measured by the Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA), differ between adults with TBI and GHD compared to those with TBI and no GHD?
  • Do fatigue, cognition, mood, post-concussion symptoms, body image, libido, perceived stress, and sleep architecture differ between these two groups?
  • Among participants with GHD who begin growth hormone replacement therapy, do symptom burden and quality of life improve over a 12-week treatment period?

Eligible participants will be asked to complete baseline questionnaires and undergo testing for growth hormone deficiency (glucagon stimulation testing). A subset of participants will also complete objective sleep assessments using actigraphy and at-home polysomnography. For those who are diagnosed with growth hormone deficiency and choose to pursue treatment, questionnaires will be repeated bi-weekly while receiving growth hormone replacement therap

Conditions

Growth Hormone Deficiency

Traumatic Brain Injury

Study ID

NCT07795736

Start date

Jun 1, 2024

Status verified date

Jul, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Inclusion criteria: Adults aged 18-70 years must be referred and have a diagnosis of mTBI made by a brain injury specialist physician and meet the 2023 ACRM diagnostic criteria (Appendix A, Panel A) or the NIH diagnostic criteria for moderate/severe TBI (Appendix A, Panel B). All participants must be symptomatic for at least one-year post-injury (determined by the Glasgow Extended Scale score of less than 8 for moderate/severe TBI and a Rivermead Post-Concussion Questionnaire score of > 13 with 3 or more symptoms scored > 3 for mTBI), at the time of screening. All participants must also be fluent in English and be able to either complete questionnaires online or over the phone.

In terms of concomitant therapies and medication, all prescription and non-prescription medications (e.g., over-the-counter drugs and herbal supplements) and therapies will be recorded by participants during baseline assessments. Participants with GHD on treatment will be asked to disclose any changes in medications/and or therapies at each bi-weekly follow up questionnaires.

Exclusion criteria include untreated pituitary deficits to minimize confounding factors (unless treated/consulted with Dr. Debert and/or Dr. Lithgow), other intracranial abnormalities, chronic neurological conditions, untreated medical conditions, major medical conditions in the past 6 months such as stroke, and current or planned pregnancy.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Suspected Growth Hormone Deficiency

Participants attending the Calgary Brain Injury Program or Chronic Pain Centre with persistent post-concussion symptoms for over 1 year suspected of having GHD.

Participants will be asked to complete the QoL-AGHDA and additional post-concussion symptom questionnaires and referred to endocrinology for provocative testing (glucagon stimulation testing)

Growth Hormone Deficiency Treatment

Participants with GHD (peak GH of < 5 mcg/L following glucagon stimulation test (GST) will be provided with growth hormone replacement (Genotropin, starting dose 0.2 ug/L and 0.3ug/L for women taking exogenous oral estrogen, Pfizer) for 3 months.

Participants will repeat the QoL-AGHDA and exploratory outcome questionnaires bi-weekly throughout treatment (3-months).

Interventions

Not applicable (observational study)

Not applicable (observational study)

Primary outcome measure

  • Quality of Life in Adult Growth Hormone Deficiency Assessment (Qol-AGHDA) [ Time Frame: To be completed at baseline and repeated bi-weekly during Genotropin treatment and treatment completion (3 months) ]
  • Glucagon Stimulation Testing [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Chantel T Debert, MD MSc FRCPC CSCN

(403) 944-4500cdebert@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T3G 5N2

Contacts

Chantel T Debert, MD MSc FRCPC

403- 944-4500cdebert@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Aug 31, 2026

Last verified

Jul, 2026

Keywords

  • Concussion
  • Persistent post-concussion symptoms
  • Traumatic brain injury
  • Growth hormone deficiency
  • Hypopituitarism
  • Quality of Life
  • Growth hormone replacement therapy
  • Post-traumatic hypopituitarism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-08-31.